"No two people see the external world in exactly the same way. To every separate person a thing is what he thinks it is -- in other words, not a thing, but a think." - Penelope Fitzgerald
TOO CLOSE TO CALL 11/7/2000George W. Bush is still ahead in electoral votes, but Arizona, Nevada, Florida and Wisconsin are too close to call.
SOUTHERN STATES 11/7/2000 George W. Bush has taken twenty states including Alabama, Georgia, Kentucky, Louisiana, Mississippi, North Carolina, South Carolina, Texas, Oklahoma, Tennessee and Virginia.
HEADLINES - INDECISION 2000 11/8/1999George W. Bush fails a test on foreign leaders, Al Gore hires a feminist author to soften his image and Stephen Colbert has phone sex with a woman in Minnesota.
ELECTION TOMORROW 11/6/2000 While Al Gore hit the road for last minute campaigning, George W. Bush dusted off his old college beer bong for the long drive to Washington.
BUSH HEADQUARTERS 11/7/2000Mo Rocca explains that the Bush campaign feels relief at the close results, since they only nominated Bush because they thought it would be kind of funny.
So politicians get paid to write laws for the people paying them and people wonder why things are getting worse. Plain madness. Trump's plan releases a tiny amount of money for the opioid crisis (clearly not enough for any sort of real crisis)...
The prescription opioid epidemic is not new. It began when Pharma rolled out and aggressively marketed time-released opioids like Oxycontin, driving “pill mills” that distributed as many as 9 million Oxys in a six-month span. What is new is the media finally calling Pharma out on the many cagey ways it got people hooked on opioids and heroin (and continues to do so), how the FDA unabashedly helps Pharma with shocking new approvals, and how people in real pain, especially the poor and African Americans, are some of the hidden victims of the epidemic. When all the reports are in, the Pharma-driven opioid epidemic may be one of the biggest and deadliest cons in recent history.
Your Patients Won’t Get Addicted, We Promise!
When Purdue Pharma and other Pharma companies began to aggressively market opioids for even minor pain, promising practitioners they were not addictive, it had been decades since the need to tightly control narcotics had been the mandate. Many newly graduating doctors, young medical professionals and their patients did not remember the opiate addictions of the 1930s, '40s and '50s and the many U.S. troops who got hooked on heroin in Vietnam. (Certainly no one remembered the notorious opium dens of early America.) Why should these drugs be so highly restricted, said Pharma, banking on the U.S.’ short memory. Why should they be restricted to short-term surgical pain, accidents and treatment of cancer and terminal pain conditions?
The misinformation was abetted by a perverse pro-opioid movement of users who claim the real problem is the media’s “misunderstanding” of opioids and overly tight controls on the pills. (After all, you are never addicted until your source is cut off.) Such vocal defenders are not a coincidence. They are the result of Pharma’s deliberate, multimillion-dollar campaigns to cast chronic pain and other nonmalignant pain conditions as requiring opioids and Pharma’s thriving parallel addiction business. Twenty years ago, none of the pain conditions now presented as requiring opioids would have been presented that way. Nor were between 40 and 52 people a day dying from opioids.
“A crippling problem.” “A total epidemic.” “A problem like nobody understands.” These are the words President Trump used to describe the opioid epidemic ravaging the country during a White House listening session in March.
The percentage of people in the U.S. dying of drug overdoses has effectively quadrupled since 1999, and drug overdoses now rank as the leading cause of death for Americans under 50.
Drugs do exist to reverse opioid overdoses or treat long-term opioid addiction. But while opioids have become easier and easier to obtain through illicit markets and sellers on the dark web, a drug that could save countless lives has become increasingly out of reach.
Consider the addiction treatment drug, Suboxone. Patents and other exclusivities on the basic version of Suboxone expired some time ago, yet the price remains sky-high, and access problems persist. Oral film strips now cost over US$500 for a 30-day supply; even simple tablets cost a whopping $600 for a 30-day supply. The cost alone puts the medication out of reach for many.
I study the pharmaceutical industry, and I see how drug companies are able to play games that keep competition out and prices high. Lack of access to addiction treatment drugs like Suboxone can be traced, in part, to the soaring prices, access problems and anti-competitive conduct that has become business as usual in the pharmaceutical industry across the board.
Patent incentives
Pharmaceutical companies have brought tremendous advances in medicine. I believe they should be adequately compensated for the enormous amount of time and resources needed to develop a new drug. Our intellectual property system is designed to do just that, rewarding companies that bring new drugs to market with a competition-free period – 20 years from the patent application date – during which they can recoup their profits.
After this defined period, generic versions of the drug are supposed to appear on pharmacy shelves, bringing down prices to levels that can be borne more easily by consumers and the health care market generally.
Brand-name companies, however, engage in myriad games to make sure theirs is the only version of the drug on pharmacy shelves, long after generics should have joined the ranks.
Martin Shkreli, the infamous pharmaceutical industry CEO responsible for hiking the cost of his company’s lifesaving drug from $13.50 to $750 overnight, once tweeted that “Every time a drug goes generic, I grieve.”
And it is not just a case of a few bad apples. Complex schemes to hold off generic competition are widespread throughout the pharmaceutical industry, as I have found in my research.
The games pharma plays, sort of like Monopoly®
Legislators on both sides of the aisle have decried sky-high drug prices, but it can be hard to pin down the specific behavior to address. Pharmaceutical game-playing has grown over the decades into a multi-headed monster, with a new tactic popping up as soon as the old one is cut off. My colleague and I set out to clearly identify and expose these various games in our book, “Drug Wars: How Big Pharma Raises Prices and Keeps Generics Off the Market.”
One game we analyzed involved the filing of petitions at the Food and Drug Administration (FDA) that raise unfounded or frivolous concerns in an effort to delay generic competitors.
Some of the petitions were just stunning to us. For example, some petitions soberly ask the FDA to require, well, what it already requires, such as ensuring that the generic drug product is stable and has an appropriate shelf life. Other petitions tie the application up in knots for reasons that are hard, even for the FDA, to discuss with a straight face.
For example, the company that manufactures the blood pressure medicine Plendil filed a petition asking the FDA to delay approval of generics by citing concerns over how different types of oranges in orange juice might affect absorption of the medication and demanding additional information on the juice used in the clinical trials.
Although 80 percent of these petitions are eventually denied, it takes time and resources for the FDA to review each petition.
Citing concerns over citizen petition games, Congress recently required the FDA to respond to such petitions within five months, but a five-month delay for a blockbuster drug can be worth hundreds of millions of dollars. (The Federal Trade Commission recently filed an antitrust suitagainst Shire ViroPharma for attempts to hold off competition related to its gastrointestinal drug Vancocin, a campaign that included 24 filings related to a single petition.) Congress also gave the FDA the ability to summarily deny petitions when appropriate, a power that the FDA has failed to use even once.
By parsing through 12 years of FDA data, we found that out of all citizen petitions filed, the percentage of petitions with the possibility of delaying generic entry doubled since 2003, rising from 10 percent to 20 percent. Thus, in some years, one in five petitions filed at the FDA on any topic, including tobacco, food and dietary supplements, had the potential to delay generic competition.
Moreover, we found that 40 percent of such petitions were filed a year or less before the FDA approved the generic, indicating that companies are using these petitions as a last-ditch effort to hold off competition.
There are plenty of other games to play, as well. For example, generic applicants need samples of the brand-name drug to show the FDA that their version is equivalent; some brand-name companies flatly refused to sell samples to generic companies.
Another common tactic involves making tiny modifications to the dosage or formulation of a drug just as the original patents are about to expire. This strategy, known as “product hopping,” allows the drug company to obtain a brand-new set of patents on their “new and improved” version of the drug.
Even if the patents are overturned – and studies show that generics convince courts to overturn the majority of patents they challenge – the process again takes time.
Much of the attention is focused on patents, but the 13 regulatory exclusivities that the FDA doles out also help create competition-free zones. These offer months or even years of additional protection, by taking steps such as carrying out pediatric studies or developing drugs for rare diseases termed “orphan drugs.” Drug companies have stretched these systems to the point at which the costs to society far outweigh the benefits.
string out games that obstruct and delay competition, one after another. As I noted when testifying before Congress about such strategies, “A billion here, a billion there; that adds up to real money.”
In 2015, 80 percent of the profit growth of the 20 largest drug companies resulted from price hikes. And drugs are vastly more expensive in the U.S. than abroad. (The liver failure drug Syprine, for example, sells for less than $400 a year in many countries; in the U.S., the average list price is US$300,000. Gilead’s hepatitis C drug, Sovaldi, reportedly sells for the equivalent of $1,000 abroad – in the U.S., it sells for $84,000.)
The industry can do this, in part, because unlike the demand for other goods, the demand for pharmaceuticals is highly inelastic. Consumers will continue to pay for the drugs that can save their lives, even if it breaks the bank.
She still refuses to admit it even though most everyone around her knows that her dependence on opioid painkillers drives nearly every part of her life. At first glance, she might look like a typical little gray-haired lady, but she lies, she cons, and she uses others in ways most of us couldn't fathom just to get the money to buy more Vicodin.
At this point, most all her family is estranged, and I am not certain she really cares. For her, the only priority is the pills. It has been this way for at least 20 years, and I’m not sure if the drug abuse made her selfish and hateful, or if she was that way before the drugs. I suspect the former. I want to believe the former. I probably need to believe the former.
As much as I would like to help her, the hard truth is that it has proven nearly impossible for any of us who are related to her to try to help her without being pulled into miserable situations ourselves. I don’t know what the answer is because I know that even as hateful and selfish as she is, she didn’t choose to be a drug addict. Circumstances beyond her control dealt her a life so terrible that she came to think of drugs as the only solution. As much as I want to be angry at her, I know in my heart that she is suffering in ways I cannot begin to understand. And frankly, I consider myself blessed, lucky, whatever you want to call it, that I cannot understand myself what she is going through.
While it might seem rare, or even a bit of a novelty, for an elderly lady to be a drug addict, it really isn’t that unusual in Appalachia. Addicts come in all ages here in the mountains. They come from rich families and from poor families. Addiction in Appalachia is not limited by race or by education level. It afflicts the Baptists and the Methodists and the Pentecostals and the agnostics. If you live in Appalachia, you almost certainly know someone who is, or was, an addict. In fact, you most likely know someone who died as a result of their addiction.
While addiction reaches both the rich and the poor in Appalachia, the stark reality is that addiction thrives in these mountains in large part because of poverty. The poverty came first. The drug addiction came later, often as a desperate response. The poor are disproportionally destroyed by addiction. They have the least access to treatment options, and they are more likely to escape addiction through death than through recovery. Most remain addicted all their lives, and their lives are usually cut tragically short.
Over the past few years, the opioid epidemic that is plaguing rural America has finally begun to get a bit of national attention. The evening news shows have run a few specials, and some documentary filmmakers have made important films about the crisis.
Today, prescription opioids have largely taken the place of heroin, methamphetamine, and crack cocaine in bringing heartache and desperation to Appalachia. These opioids don't come across the southern border or from a clandestine lab or even from a trailer park chemist. They come from multi-national corporations. They are prescribed by physicians, and purchased and dispensed, at least initially, from licensed pharmacies. The most popular form is called Oxycodone. You might know it by one of its brand names: OxyContin, Roxycodone, or Percocet. A closely-related drug, hydrocodone, is sold under brand names including Vicodin, Lorcet, and Norco. In much of Appalachia, these drugs, all of which are opioids, are household names.
HARD-HITTING NEWS ON "HARD CHOICES" 6/18/2014CNN and Fox News manage to land exclusive interviews with Hillary Clinton on the same day, an accomplishment apparently warranting its own extensive coverage.
CHENEY HEALTH 12/5/2000Republican spin doctors are asking the public to consider Dick Cheney's hard trouble within the context of his other organs.
HEADLINES - ELECTOR COMPLEX 12/7/2000The Republican-controlled Florida state government calls a session in order to uphold the Constitution, not to engage in partisan politics.
An Overview Of The GOP/Republicans With The Daily Show
